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Dynamic Humeral Centering in Impingement Syndrome (ADHCIS)

Primary Purpose

Degenerative Rotator Cuff Disease With Impingement Syndrome

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dynamic humeral centering
Nonspecific mobilisation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Rotator Cuff Disease With Impingement Syndrome focused on measuring Degenerative rotator cuff disease, Impingement syndrome, Dynamic humeral centering, Randomized clinical trial

Eligibility Criteria

31 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 30 years
  • pain duration > 1 month
  • presence of at least 2 positive impingement test results from Neer, Yocum and Hawkins testing
  • total Constant score < 80.

Exclusion Criteria: concerning the shoulder

  • stiffness
  • anteroposterior instability
  • tendinous calcification
  • corticosteroid injection within the previous 30 days
  • previous surgery
  • humeral fracture
  • inflammatory joint disease
  • neoplastic disorders

Sites / Locations

  • Department of Rheumatology, Lariboisière Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: Dynamic humeral centering

2: Nonspecific mobilisation

Arm Description

Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.

Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.

Outcomes

Primary Outcome Measures

Constant total score as a mean and by category

Secondary Outcome Measures

Constant total score
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use

Full Information

First Posted
November 30, 2009
Last Updated
November 30, 2009
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Societe Francaise de Rhumatologie
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1. Study Identification

Unique Protocol Identification Number
NCT01022775
Brief Title
Dynamic Humeral Centering in Impingement Syndrome
Acronym
ADHCIS
Official Title
Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Societe Francaise de Rhumatologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder
Detailed Description
Clinical trial with randomization for treatment and physiotherapist

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Rotator Cuff Disease With Impingement Syndrome
Keywords
Degenerative rotator cuff disease, Impingement syndrome, Dynamic humeral centering, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Dynamic humeral centering
Arm Type
Experimental
Arm Description
Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
Arm Title
2: Nonspecific mobilisation
Arm Type
Active Comparator
Arm Description
Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
Intervention Type
Procedure
Intervention Name(s)
Dynamic humeral centering
Intervention Description
Dynamic humeral centering performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
Intervention Type
Procedure
Intervention Name(s)
Nonspecific mobilisation
Intervention Description
Nonspecific mobilisation performed for 6 weeks, in 15 supervised individual outpatient sessions, plus daily home exercises for 12 months.
Primary Outcome Measure Information:
Title
Constant total score as a mean and by category
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Constant total score
Time Frame
at 12 months
Title
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Time Frame
at 3 months
Title
Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 30 years pain duration > 1 month presence of at least 2 positive impingement test results from Neer, Yocum and Hawkins testing total Constant score < 80. Exclusion Criteria: concerning the shoulder stiffness anteroposterior instability tendinous calcification corticosteroid injection within the previous 30 days previous surgery humeral fracture inflammatory joint disease neoplastic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann BEAUDREUIL, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, Lariboisière Hospital
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25185788
Citation
Beaudreuil J, Ostertag A, Lasbleiz S, Vicaut E, Yelnik A, Bardin T, Orcel P. Efficacy of dynamic humeral centering according to Neer test results: a stratified analysis of a randomized-controlled trial. Int J Rehabil Res. 2015 Mar;38(1):81-3. doi: 10.1097/MRR.0000000000000079.
Results Reference
derived
PubMed Identifier
21623001
Citation
Beaudreuil J, Lasbleiz S, Richette P, Seguin G, Rastel C, Aout M, Vicaut E, Cohen-Solal M, Liote F, de Vernejoul MC, Bardin T, Orcel P. Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1613-8. doi: 10.1136/ard.2010.147694. Epub 2011 May 29.
Results Reference
derived

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Dynamic Humeral Centering in Impingement Syndrome

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